PSW 1301.U

FDA registration

BIOTRONIK, INC.·5 products·🇺🇸 United States

Selectra 3D-65-39

FDA registration

BIOTRONIK, INC.·1 product·🇺🇸 United States

SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75

FDA 510(k)

FDA Class 2 ·Cardiovascular

Renamic

FDA registration

BIOTRONIK, INC.·5 products·🇺🇸 United States

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/ RENAMIC PROGRAMMERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000 IMPLANT CONTROL SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IMPLANT CONTROL SYSTEM (ICS) 3000

REVIVE INTERMEDIATE CATHETER (REVIVE IC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lumax

FDA registration

BIOTRONIK, INC.·7 products·🇺🇸 United States

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM ICS MODELS 1850, 1851, 18521853

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000 IMPLANT MODULE AUTOMATED TEST

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO II DR/VR, SECURA DR.VR, MAXIMO II DR/VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (ICS 3000 802.U/2)